The judgment of the High Court of England and Wales in Cardiorentis AG v IQVIA Ltd & Another appears to be the first common law court’s decision that gives detailed consideration to the duties of companies involved in the conduct of clinical trials and, in particular, the standard of care owed by contract research organisations (‘CRO’). The court dismissed Cardiorentis’ claim for damages in excess of €300 million in respect of a clinical trial run by IQVIA. This is a significant decision in an area that is ripe for high value, complex disputes.
Cardiorentis, a Swiss pharmaceutical company, engaged IQVIA, a CRO, to manage a phase III clinical trial designed to evaluate the efficacy and safety of its drug Ularitide, developed to treat patients with acute decompensated heart failure. When the results showed that Ularitide was not efficacious, Cardiorentis brought a claim against IQVIA alleging that IQVIA failed to provide services to the agreed standard of care ‘customary in the CRO industry’, in particular in respect of training, monitoring and reporting procedures, and that that rendered the results from the trial invalid
The High Court’s decision
The court held that the results of the clinical trial were reliable and, accordingly, that IQVIA had not breached its contractual/regulatory obligations and had performed its services reliably and with the requisite standard of care.
The following findings are of particular note:
- As is standard in the industry, Cardiorentis, as sponsor, had not contracted IQVIA, as CRO, to conduct a clinical trial that would produce a particular result. Cardiorentis had contracted for the conduct of a study which produced a meaningful and interpretable result, positive or negative, regarding the efficacy of the drug.
- The question of what constitutes the standard of reasonable skill and care / the care customary in the CRO industry is one to be determined by the court, assisted by evidence, including expert evidence. However, documents governing the clinical trial gave an indication of the relevant standard of reasonable skill and care and the standard customary in the CRO industry.
- Protocol deviations are to be expected in clinical trials.
- A clinical trial of an acute condition, where a decision on enrolment has to be made quickly in challenging conditions in an emergency room, is likely to produce a higher level of eligibility deviations from that of a study of a chronic condition, where eligibility decisions can be taken more deliberately.
- There is no recognised threshold or cut off in the number or percentage of protocol deviations which would mean that regulators or the scientific community would consider the study to be unreliable.
Please contact Henry Stewart or Laurence Harris should you wish to discuss anything related to the above decision.
  EWHC 250 (Comm)